| CTRI Number |
CTRI/2025/03/083495 [Registered on: 26/03/2025] Trial Registered Prospectively |
| Last Modified On: |
25/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effect of Combined Repetitive Transcranial Magnetic Stimulation and Virtual Reality on Hand Function, Grip Strength, Daily Activities, and Self-Efficacy in Subacute Hemiplegic Stroke: A Randomized Placebo-Controlled Trial |
|
Scientific Title of Study
|
Efficacy of combined repetitive transcranial magnetic stimulation and virtual reality versus sham transcranial magnetic stimulation on hand function, grip strength, daily activities, and self efficacy in subacute hemiplegic stroke- a randomized placebo controlled trial
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sakshi Ravindra Borkute |
| Designation |
Junior Resident |
| Affiliation |
Ravi Nair Physiotherapy College |
| Address |
Neuroscience Physiotherapy OPD Ravi Nair Physiotherapy College ,Datta Meghe Institute of Higher Education And Research (DU), Sawangi(Meghe)Wardha 442001, Maharashtra
Ravi Nair Physiotherapy College ,Datta Meghe Institute of Higher Education And Research (DU), Sawangi(Meghe)Wardha 442001, Maharashtra
Wardha
MAHARASHTRA
442001
India |
| Phone |
9307434589 |
| Fax |
|
| Email |
sakshiborkute2000@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Raghuveer Raghumahanti |
| Designation |
Professor Of Neurophysiotherapy |
| Affiliation |
Ravi Nair Physiotherapy College |
| Address |
Neuroscience Physiotherapy OPD Ravi Nair Physiotherapy College ,Datta Meghe Institute of Higher Education And Research (DU), Sawangi(Meghe)Wardha 442001, Maharashtra
Ravi Nair Physiotherapy College ,Datta Meghe Institute of Higher Education And Research (DU), Sawangi(Meghe)Wardha 442001, Maharashtra
Wardha
MAHARASHTRA
442001
India |
| Phone |
8126506769 |
| Fax |
|
| Email |
raghuneuro@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Sakshi Ravindra Borkute |
| Designation |
Junior Resident |
| Affiliation |
Ravi Nair Physiotherapy College |
| Address |
Neuroscience Physiotherapy OPD Ravi Nair Physiotherapy College ,Datta Meghe Institute of Higher Education And Research (DU), Sawangi(Meghe)Wardha 442001, Maharashtra
Ravi Nair Physiotherapy College ,Datta Meghe Institute of Higher Education And Research (DU), Sawangi(Meghe)Wardha 442001, Maharashtra
Wardha
MAHARASHTRA
442001
India |
| Phone |
9307434589 |
| Fax |
|
| Email |
sakshiborkute2000@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ravi Nair Physiotherapy College ,Datta Meghe Institute of Higher Education And Research (DU), Sawangi(Meghe)Wardha 442001, Maharashtra, India. |
|
|
Primary Sponsor
|
| Name |
Ravi Nair Physiotherapy College |
| Address |
Ravi Nair Physiotherapy College ,Datta Meghe Institute of Higher Education And Research (DU), Sawangi(Meghe)Wardha 442001, Maharashtra, India. |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Sakshi Ravindra Borkute |
Aacharya vinoba bhave rural Hospital |
Neuroscience Physiotherapy OPD Sawangi, Wardha Maharashtra, India 442001
Wardha
MAHARASHTRA |
09307434589
sakshiborkute2000@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta Meghe Institute of Higher Education and Research (DU) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G998||Other specified disorders of nervous system in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Combined repetitive transcranial magnetic stimulation and virtual reality exercises |
Combined repetitive transcranial magnetic stimulation and virtual reality exercises adjunct to conventional therapy for 6 weeks |
| Comparator Agent |
Conventional Physiotherapy |
Virtual Reality |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Subjects with ischemic or haemorrhagic stroke diagnosed by a neurologist or a clinician confirmed by physical and radiological findings CT or MRI
Subjects in the subacute phase of stroke greater than 3 months following stroke
Both men and women aged from 45 to 65 years 9
Subjects should be maintain lumbricals position
Tone measured through Modified Ashworth Scale should be greater than equal to 1 plus
Patients with Brunnstrom stage for hand greater than equal to 410
MMSE score should be 25 or higher normal cognitive status
Subjects who have provided a consent to participate in the study
|
|
| ExclusionCriteria |
| Details |
Subjects with traumatic brain injury TBI spinal cord injury SCI cancer patients
Subjects with recent upper limb fractures serious orthopaedic conditions
Subjects with intracranial metallic implants and pacemakers
Subjects with epilepsy
Enrolment in another clinical trial involving physiotherapy
individuals suffering from unstable angina symptomatic heart failure or uncontrolled hypertension
Recurrent and Acute stroke flaccid stage
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Fugl-Meyer Upper Extremity (FMUE)
Hand held Dynamometer 6. Upper limb self efficacy questionnaire 5. The Motor Activity Log (MAL) modified ashworth scale
|
Fugl-Meyer Upper Extremity (FMUE)
Hand held Dynamometer 6. Upper limb self efficacy questionnaire 5. The Motor Activity Log (MAL) modified ashworth scale
Baseline, 4 weeks , 6 weeks and 2 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Stroke Impact Scale |
Baseline 4 weeks, 6 weeks & 2 months |
|
|
Target Sample Size
|
Total Sample Size="46"
Sample Size from India="46"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/04/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [sakshiborkute2000@gmail.com].
- For how long will this data be available start date provided 18-03-2025 and end date provided 18-03-2030?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Problem of the studyThe study on the efficacy of combined repetitive transcranial magnetic stimulation (rTMS) and virtual reality (VR) exercises in motor recovery, grip strength, activity, and self-efficacy in subacute stroke patients addresses a critical gap in stroke rehabilitation. While individual therapies such as rTMS and VR exercises have shown promise in improving motor function and neuroplasticity, there is limited research on their combined effects in the subacute phase of stroke recovery. This period is crucial for maximizing recovery potential, as patients are often still undergoing significant neural plasticity. The need for this study arises from the potential of combining non-invasive brain stimulation (rTMS) with immersive, task-specific training (VR) to enhance motor recovery more effectively than either intervention alone. By examining outcomes like grip strength, functional activity, and self-efficacy, the study aims to provide insights into how these therapies can work synergistically to improve both physical and psychological aspects of rehabilitation, thereby advancing treatment strategies for subacute stroke patients. |